Kornimate/medical-research-clean huggingface dataset:
trans abdominal plane block (tap block) in surgery of stoma reversal and its effect on post operative recovery: a prospective, randomized, muticenter study

Conditions: Surgery; Stoma Ileostomy

Summary: the primary purpose of tapas study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (tap block) performed at the beginning of stoma reversal, compared to standard of care. the hypothesize is that a tap block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time

the patient will arrive in the department the day before the surgical intervention (d-1). during this preoperative visit (d-1), the investigator * will preselect potentially eligible patients * will offer to participate to this study * will give the notice form to the patients * will present the research: objectives, benefits and constraints for the patients the intervention day (d0): the investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria. the randomization will be done via the ecrf module (allocation group and number) and the preoperative data registration in the ecrf. surgical intervention (d1): all patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. prevention of nausea and vomiting is performing using apfel score. anti microbial prophylaxis is performed according recommendations. all patients will receive post operative multimodal analgesia using, acetaminophene, ketaminophene (if no contra indication), nefopam, and morphine if nrs (numerating rating scale) \> 3 at the end of the surgery, patients in the experimental group will receive a ultrasound guided trans abdominal plane block with 20 ml of 5 mg/mg of ropivacaine. patients in the control group will not receive the block

Eligibility criteria:
inclusion criteria: * age \> 18 years old * patients operated of a scheduled stoma reversal surgery * patients having given consent in the mannen described in article l1122-1-1 of the public health code * patients affiliated with asocial security regimen or beneficiary of such a regimen exclusion criteria: * renal insufficiency (ie glomerular filtration output \< 35 ml/min) * patients with chronic inflammatory bowel disease * body mass index \> 35 kg/m2 * chronic pain with opiates * patients with cognitive troubles * coagulation disorders (platelets count \< 80g/l, pt\< 50%, v factor \< 50%) * pregnancy * breastfeeding * local anesthesics (amide class) allergy

Keywords: prospective randomized pilot study trans abdominal plane block quo r 40 score post operative pain
sipit2: improving adherence to fluid intake guidelines for kidney stone prevention

Conditions: Urolithiasis

Summary: the purpose of this study is to examine the feasibility of using sipit tools (i.e., wrist-worn sensors, smart water bottles, mobile applications) to increase compliance with physician-recommended fluid consumption guidelines in participants with a history of urolithiasis.

the study uses a randomized controlled trial design with a 12-month intervention period and outcome assessments at baseline, 1, 3, and 12 months. participants will be randomly assigned to groups. both groups will receive usual care which involves education about fluid intake guidelines and encouragement to adhere to those guidelines from a clinician. the intervention group will additionally receive the sipit intervention comprising a semi-automated fluid intake tracking system and context-sensitive, just-in-time notifications reminding them to drink.

Eligibility criteria:
inclusion criteria: * previous diagnosis of symptomatic kidney stone in past 5 yrs * 24-hr urine volume ≤ 2.0 l/day, * age 18 or older, * own ios or android smartphone, * proficient in english language, * capable of providing informed consent, and * willing to use a fitbit smartwatch, connected water bottle, and mobile app for the study every day for a year, and receive text messages reminder to drink. exclusion criteria: * previous diagnosis with cystine stone, * pregnant or planning to become pregnant in the next 12 months, * concurrently participating in another study involving fluid intake or diet, * plan to have surgery or relocate outside the area within the next year * co-morbidities that preclude high fluid intake, conditions with high fluid losses (e.g., congestive heart failure, bariatric surgery, gi tract ostomy, short gut syndrome, chronic diarrhea including patients with ulcerative colitis/crohn's disease, hyponatremia), or conditions that preclude ability to collect 24-hour urine (severe urinary incontinence), * active medical treatments that would impair protocol compliance, * chronic use of lithium, or * psychiatric conditions impairing compliance with the study protocol.
effect of pre-operative depo medroxyprogesterone acetate on serum anti-mullerian hormone level after laparoscopic ovarian cystectomy of endometriomas

Conditions: Endometriosis

Summary: the purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (dmpa) in women with ovarian endometrioma undergoing laparoscopic cystectomy.


Eligibility criteria:
inclusion criteria: * healthy women 18-40 years old * a diagnosis of endometrioma with diameter of at least 3 cm. * candidates for laparoscopic cystectomy exclusion criteria: * patients' refusal to participate * not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis * use of estrogen-suppressive drugs in the preceding 3 months, such as: oral contraceptives, gnrh analogues, progestins, danazol * pathology report present no endometriosis
combined mode-kinetic chain exercise with and without core stability exercises on patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the goal of this \[type of study: randomized control trial\] is to \[ see the effects of combined mode kinetic chain exercises along with or without core stability exercises on pain, range of motion and disability \] in \[ in patients with knee osteoarthritis\].the main question it aims to answer is: wether core stability exercises is effective if performed along with combined chain kinetic exercises to improves the condition of knee osteoarthritis? group a will receive core stability exercises along with combined chain kinetic exercises and group b will receive combined chain kinetic exercises.

knee joint osteoarthritis is a prevalent and multifaceted condition, affecting a substantial portion of the general population (roughly 13% of women and 10% of men 60 years). different techniques and treatment methods have been used to treat knee osteoarthritis. in this study, i will be identifying that core stability exercise if performed along with combined chain kinetic exercise brings benefits to the patients of knee osteoarthritis. one of the techniques is combined chain kinetic exercise that i will be applying on both groups. the other one is the set of core stability exercises. the research involves two intervention groups (group a and group b) receiving specific treatments over 60 sessions within an twelve-week period. group a incorporates the combined chain kinetic exercise,core stability exercises, and transcutaneous electrical nerve stimulation (tens) with a heating pad. group b undergoes hot packs and tens, followed by combined chain kinetic exercise, encompassing pain levels, range of motion (rom), and knee injury and osteoarthritis outcome score (koos) scores, will be evaluated using the numeric pain rating scale, goniometer, and koos. data analysis will employ spss version 26. data will be collected at baseline, immediately post-intervention, and at follow-up intervals.

Eligibility criteria:
inclusion criteria: * age 40 to 70 years with knee osteoarthritis exclusion criteria: * participants suffering from any other condition of knee joint or if they are in active infection state

Keywords: kinematic chain exercises, knee osteoarthritis, pain
virological and immunological safety of a dose reduction strategy antiretroviral regimen with efavirenz / tenofovir / emtricitabine

Conditions: HIV

Summary: the main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of atripla ®.

the main objective of this study is to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / ml) of a dose reduction strategy of atripla ® once a day to three tablets per week in patients infected with hiv-1 with sustained suppression of plasma viral load standard for more than two years.

Eligibility criteria:
inclusion criteria: * adults (≥ 18 years) * hiv-1 infection, clinical stability, and treatment with atripla ® for the past two years. * standard plasma viral load below the limit of detection for at least 2 years. * cd4 count above 350/mm3 at the time of the consideration for the study. * negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug. * patients should be given written informed consent * in the opinion of the investigator, be able to follow the design of the protocol visits exclusion criteria: * patients who have experienced virologic failure prior to any antiretroviral regimen * evidence of previous mutations versus efavirenz, tenofovir and emtricitabine * use of any other chronic treatment plus atripla has been introduced in the 6 months prior to entry of the patient in the study * any contraindication to study drug * any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient * uncontrolled preexisting psychiatric illness * any current sign of alcoholism or other drug use.
topical hydrocortisone for pain and edema control after third molar surgery

Conditions: Impacted Third Molar Tooth

Summary: the investigators set out to develop a clinical trial in order to test the topical use of hydrocortisone as a intraoperative irrigant solution. as this route of administration as well as being low cost and not add new steps to the surgical procedure, can contribute to an improved quality of life in the postoperative period of patients undergoing extraction of third molars.

third molars are the teeth with a higher prevalence of failure in eruption and surgery for extraction of these impacted teeth is one of the most commonly procedures performed by the oral and maxillofacial surgeon. in most cases these are not traumatic procedures, however factors such as patient age, habits, degree of tooth impaction and surgeon experience can influence the surgical trauma and therefore the postoperative period could include swelling and pain of varying magnitudes which can significantly affect the patient's quality of life. the study is designed as a prospective, randomized, placebo-controlled, split-mouth crossover trial. all the patients will be informed of the experimental methodology and signed a institutionally approved consent form. the study is been conducted in compliance with declaration of helsinki (1989), and was revised by the institutional ethical committee (protocol 1.167.908).

Eligibility criteria:
inclusion criteria: * health patients of any sex, with symmetric bilateral bone-impacted mandibular third molars requiring surgical removal, and with no history of allergy to the drugs used in this study. exclusion criteria: * use of analgesic or anti-inflammatory drugs 24 hours before the surgery. * pregnant or breastfeeding patients, * use of other drugs beyond of that one's prescribed by the researchers;

Keywords: hydrocortisone third molar oral surgery postoperative pain edema
dft383 in pediatric participants with nephropathic cystinosis

Conditions: Nephropathic Cystinosis

Summary: an open-label, multi-center, phase i/ii study to assess the safety, tolerability and efficacy of dft383 in pediatric participants with nephropathic cystinosis. the purpose of this clinical study is to assess safety, tolerability, and efficacy of dft383 in participants aged 2 to ≤ 5 years with nephropathic cystinosis. dft383 is a cellular gene therapy. this study includes an active arm (cohort 1) of participants treated with study treatment dft383 and a concurrent reference arm (cohort 0) treated with standard of care (soc). the study is not randomized and cohort 0 aims to collect prospective and concurrent data in this rare disease.

this study is an open-label, multi-center, phase i/ii study to assess the safety, tolerability, and efficacy of dft383 in participants aged 2 to 5 years with nephropathic cystinosis. the study consists of participants receiving dft383 in cohort 1 and standard of care (soc) in cohort 0. the two cohorts will be run in parallel. investigational sites may participate in one or both cohorts. cohort 1 approximately 15 participants will receive treatment with dft383 in 3 cohorts (1a, 1b and 1c) dosed in a staggered approach. the total study duration for a participant in cohort 1 will be up to 32 months. cohort 0 approximately 15 participants meeting similar inclusion/exclusion criteria and receiving soc will be enrolled. the schedule of activities will be reduced for this cohort. this cohort 0 is not a direct control but will provide essential context for interpreting the results observed in the participants receiving dft383. the total study duration for a participant in cohort 0 will be up to 24 months.

Eligibility criteria:
key inclusion criteria: participants eligible for inclusion in this study must meet all the following criteria: 1. informed consent in writing from parent(s) or legal guardian(s) must be provided 2. 2 to 5 years of age (including 5 years and 364 days old) at screening 3. weight-for-stature is ≥ the third percentile is ≥ 10 kg 4. oral cysteamine therapy for at least 6 months 5. historic clinical diagnosis of nephropathic cystinosis 6. laboratory evidence of of renal fanconi syndrome (rfs) 7. preserved kidney function (egfr ≥ 90ml/min/1.73m2) 8. received all age-appropriate vaccinations key exclusion criteria for cohort 1 and 0 1. a history of kidney transplantation 2. a prior or planned bone marrow or stem cell transplantation or prior treatment with gene therapy 3. history of malignancy 4. a severe or uncontrolled medical disorder 5. major surgery within 90 days additional key exclusion criteria for cohort 1 - the following exclusion criteria only apply to cohort 1 only as they are important for procedures related to dft383 treatment: 1. indomethacin within 2 weeks prior to screening other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cystinosis nephropathic cystinosis lysosomal storage disorder ctns gene dft383 cellular gene therapy cysteamine renal fanconi syndrome
regional differences of cutaneous irritation and its effect on skin barrier recovery

Conditions: Irritant Contact Dermatitis

Summary: irritant contact dermatitis induced by sodium lauryl sulphate (sls) is often used as a model for testing efficacy of various topical preparations. aforementioned model is standardized and described in guidelines, but it is not explicitly stated where the irritation should be induced. published clinical trials usually irritate volar aspect of forearms or upper back. also, lower back and dorsal aspect of forearm are sometimes used. skin parameters vary depending on anatomic location of measured skin. there is a difference in stratum corneum thickness, hydration and transepidermal water loss across different locations, including between volar forearm and upper back. furthermore, regional difference in skin response to irritation by tape stripping and benzalkonium chloride were observed. such differences are also possible in sls irritation model. one study has shown higher, but not statistically significant, response of back in comparison to forearms, but it had a very small sample size (n=9). moreover, there are regional variations of topical preparations absorption. hydrocortisone had 1,7 times higher absorption when applied to upper back in comparison to forearms. those variations could be explained by different corneocyte size and number of their layers between back and hands. skin baseline properties and response to irritation seem to be dependent on anatomic position. those differences could mean different response to treatment. since published trials only tested efficacy of various preparations on one anatomic location, it is possible their results would be different if tested on other body parts. it could limit validity and usefulness of conducted trials. the aim of this study is to determine if there are regional differences of skin response to irritation and emollient cream treatment in irritant contact dermatitis model.


Eligibility criteria:
inclusion criteria: * young, healthy volunteers who gave written informed consent exclusion criteria: * skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior the inclusion and during the trial, use of emollients three days prior the inclusion in the trial, non-adherence to the trial protocol, exposure to artificial uv radiation, pregnancy and lactation

Keywords: irritant contact dermatitis sodium lauryl sulphate emollients transepidermal water loss
cerebral computed tomography on patients with minor head injuries

Conditions: Computed Tomography; Minor Head Injuries

Summary: this observational study aims to calculate the prevalence of conditions or diseases requiring immediate medical attention in ctc scans with an indication of bleeding post trauma performed in the ed at odense university hospital. secondary, we aim to evaluate the scandinavian neurotrauma committee clinical guideline 2013 for minor head injury.

in this retrospective study, our primary objectives are threefold: first, to calculate the prevalence of conditions or diseases requiring immediate medical attention and to subdivide them to explore potential correlations with biochemical, clinical, and patient baseline variables using multiple regression analysis. secondly, we wanted to analyze our use of snc cpg and evaluate if a more stringent application could reduce the potentially unnecessary overuse of ctc. lastly, we aim to evaluate the 30-day mortality and readmission rates to a hospital following ctc performed in the ed.

Eligibility criteria:
inclusion criteria: * ctcs conducted from 01.01.2023 to 31.12.2023 in the ed exclusion criteria: * unrelated to trauma * scans performed on patients under the age of 18 * ctc scans without radiologic interpretation * previously undergone a ctc during the same hospitalization, only the first ctc was included

Keywords: emergency department s100b scandinavian neurotrauma committee guideline traumatic brain injuries
preoperative acetaminophen and carbohydrate loading

Conditions: Non-melanoma Skin Cancer

Summary: the study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing mohs micrographic surgery for non-melanoma skin cancers. patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and gatorade sports drinks 2 packets before surgery. patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.


Eligibility criteria:
inclusion criteria: * adult patients undergoing mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma) exclusion criteria: * history of liver transplant, hepatitis, or cirrhosis, those required to be npo for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen

Keywords: mohs micrographic surgery pain functional status
stimpulsecontrol ancillary speech study

Conditions: Parkinson Disease; Impulse Control Disorder

Summary: speech assessment is a substudy to the stimpulsecontrol study (hereinafter referred to as the main study), where audio recordings of patients voices will be recorded as part of a speech analysis in the main study, for this optional ancillary study.

speech of all study patients enrolled in the stimpulsecontrol main study will be recorded at three points of time in a standardized way. following this ancillary protocol, patients speech will be recorded at the baseline visit (preoperatively), at the 6-months visit and at the 12-months visit postoperatively. for the baseline speech assessment the same protocol will be performed in chronic medication conditions. at 12-month follow up, we will repeat the speech protocol in chronic medication and stimulation condition. the recordings will be done in each centre in a decentralized way and the audio files will be produced according to a standardized protocol, and assisted by a step-by-step guided speech recording software. main aims and hypothesis for automated speech analysis study are safety measures for surgical interventions in pd assessment of parkinsonian (hypokinetic) motor speech features outcome after stn-dbs, assessment of dyskinetic (hyperkinetic) motor speech features outcome after stn-dbs, assessment of capsular speech features outcome after stn-dbs in pd emotional and cognitive speech outcomes to be used in surgical and pharmacological interventions in pd assessment of acoustic and linguistic speech features as proxy for behaviour and cognitive changes in pd, comparison of emotional and cognitive speech outcomes before and 1-year after stn-dbs + bmt vs bmt alone.

Eligibility criteria:
inclusion criteria: please refer to main study (stimpulsecontrol kks-313) exclusion criteria: please refer to main study (stimpulsecontrol kks-313)

Keywords: speech
otitis media with effusion and type 2 inflammation diseases

Conditions: Otitis Media With Effusion

Summary: otitis media with effusion (ome) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. many of these comorbidities can be caused by type 2 inflammation (t2i). this study aims to characterize the risk of undergoing ome surgery. this retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the taiwan national health insurance research database (nhird)


Eligibility criteria:
inclusion criteria: * diagnosis of ome * at least two outpatient visits or one hospitalization record * medical records within the database exclusion criteria: * participants younger than 4 years old * participants with unclear demographic information * participants with a history of ear surgery or congenital ear anomalies * participants who had undergone ome surgery before the index date